BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT

    MDR report key: 2571178 · Received May 7, 2012

    Report

    Report Number
    MW5025342
    Event Type
    Malfunction
    Date Received
    May 7, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 7, 2012
    Manufacturer
    ABBOTT PUERTO RICO MANUFACTURING
    Product Code
    KYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROBLEM OCCURRED DURING CASE IN OPERATING ROOM FOR CATARACT REMOVAL AND IMPLANTING AN INTRAOCULAR LENS (IOL). A CARTRIDGE IS USED FOR EJECTING THE IOL INTO THE EYE. IN THIS CASE, AND SEVERAL OTHERS AT OUR AMBULATORY SURGERY CENTER, WHEN THE IOL IS LOADED INTO THE CARTRIDGE, THE IOL GOES THROUGH THE CARTRIDGE PLASTIC LEAVING A JAGGED EDGE OR A HANGING PIECE OF THE CARTRIDGE. THIS IS INSTEAD OF THE LENS BEING LOADED THROUGH AN OPENING AT THE END OF THE CARTRIDGE. IF PLACED INTO THE EYE, THIS PIECE COULD BREAK OFF IN THE EYE OR THE JAGGED EDGE COULD CAUSE DAMAGE. WE HAVE HAD 4 CARTRIDGES CRACK AT OUR AMBULATORY SURGERY CENTER WITHIN THE LAST SEVERAL MONTHS. THIS PT WAS THE CASE IN WHICH THIS OCCURRED. FORTUNATELY, WE HAVE NOT PUT THE CARTRIDGE INTO THE EYE BECAUSE OUR SURGEON AND/OR THE SCRUB TECH HAVE NOTICED THE CRACK. THEY HAVE LOADED THE LENS INTO THE CARTRIDGE AND HAVE MANY YEARS EXPERIENCE IN EYE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT INJECTION CARTRIDGE KYB ABBOTT PUERTO RICO MANUFACTURING 1MTEC30 CK00136

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR AN ABBOTT INTRAOCULAR LENS WAS PLACED IN THE| CARTRIDGE.